Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04873362 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
A Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 1,188
- Enrollment target
- 20
- Study locations
NCT04873362: Active Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
NCT04873362 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 1,188 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04873362, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,188 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. As of June 4, 2024, this study is no longer accepting any newly screened participants.
Primary Outcome
IDFS event is defined as the time from randomization to the first occurrence of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, death from any cause.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Placebo
- DRUG Atezolizumab
- DRUG Trastuzumab Emtansine
Study Locations (20)
Virginia
- Hematology Oncology Associates of Fredericksburg, Inc. - Fredericksburg
- Virginia Oncology Associates - New Port News - Newport News
- Virginia Oncology Associates - Norfolk
- Virginia Cancer Institute - Richmond
- Virginia Oncology Associates - Virginia Beach - Virginia Beach
California
- Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center - Buena
- UCLA Medical Center - Santa Monica
- Innovation Clinical Research Institute - Whittier
Tennessee
- The West Clinic - Germantown
- Thompson Cancer Survival Center - Knoxville
Alabama
- Alabama Oncology - Birmingham
Florida
- Florida Cancer Specialists - West Palm Beach
Georgia
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital - Carrollton
Iowa
- University of Iowa - Iowa City
Maine
- New England Cancer Specialists - Westbrook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,188 participants |
| Start Date | 2021-05-04 |
| Est. Completion | 2034-10-02 |
| Phase | Phase 3 |
What the registry record for NCT04873362 still lists
NCT04873362 is an interventional study that assigns participants to a tested intervention. Its 1,188 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.
NCT04873362 names 20 study sites across 13 states, led by Virginia, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04873362 about?
NCT04873362 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy". This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in th...
What is the current status of trial NCT04873362?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,188 participants. The study started on 2021-05-04. Estimated completion is 2034-10-02.
What conditions does trial NCT04873362 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04873362?
The interventions under investigation include: Trastuzumab (DRUG), Placebo (DRUG), Atezolizumab (DRUG), Trastuzumab Emtansine (DRUG).
Who is sponsoring clinical trial NCT04873362?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04873362 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04873362's enrollment target sits among peer trials
1,188 106th of 1224 higher than 1,119 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
RECRUITING · Phase 3
-
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
RECRUITING · Phase 3
-
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
RECRUITING · Phase 3
-
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
RECRUITING · Phase 3
-
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05580419 · 1,188 participants · NA
Impact of 4PCP on Practitioner and Patient Outcomes
- NCT06290869 · 1,188 participants · Phase 3
Tobacco Education and Lung Health Study (TEAL)
- NCT04293562 · 1,186 participants · Phase 3
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
- NCT07286058 · 1,182 participants · Phase 3
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI